Comparison of the average superoxide dismutase enzyme in the groups receiving selenium and n-acethylcysteine antioxidants in severe trauma patients admitted to an intensive care unit
Comparison of the average superoxide dismutaseenzyme in the groups receiving selenium and n-acethylcysteine antioxidants in severe trauma patients admitted in an intensive care unit.
Design
Randomised, single blind Clinical trial on severe trauma patients. After determination of the sample size by blocked randomization method
patients divided into three groups of twenty patients (2 patientes in the case group1and 2 patients in case group 2 and 2 patients in control group)
Settings and conduct
this research is a single blind clinical trial on cases with severe trauma in admited in the ICU ofkerman Bahonar hospital in the year 1398.
Patients were randomly divided into three groups according to age and sex. After explaining to the patients family about the research and taking the written consent the patients will be entered in to the research.
protocol to receive medication:
first group will receive N-acetyl cystine as the protocol.
also second group will under go treatment with Selenium as per the protocol
and the control group will receive placebo.
on the third day we take 5cc serum sample from the participant (in the test tube without anti-coagulant ) and we analyze the supra oxidant activity based on the ELISA method using Pajohan Teb kit.
Participants/Inclusion and exclusion criteria
Inclusion criteria age 18 years old and up .Exclusion criteria incomplete demographic factor. underlying disease.organ failaure .drug sensitivity.
Intervention groups
patients are divided into 3 groups
first group will go under N-acetyl cysteine treatment as per the protocol,
second group will under go treatment by selenium as per the protocol .
control group will receive placebo. The test will be takekn3 days later after first dose
Main outcome variables
superoxide desmotaze؛ hospitalization period ؛level of concsiousness ؛organ failure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201109049317N1
Registration date:2021-05-03, 1400/02/13
Registration timing:retrospective
Last update:2021-05-03, 1400/02/13
Update count:0
Registration date
2021-05-03, 1400/02/13
Registrant information
Name
Leili Asadabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 8067
Email address
asadabadi.l@vums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-05, 1398/05/14
Expected recruitment end date
2019-11-05, 1398/08/14
Actual recruitment start date
2019-11-11, 1398/08/20
Actual recruitment end date
2019-11-11, 1398/08/20
Trial completion date
2020-02-10, 1398/11/21
Scientific title
Comparison of the average superoxide dismutase enzyme in the groups receiving selenium and n-acethylcysteine antioxidants in severe trauma patients admitted to an intensive care unit
Public title
Effect of selenium and n-acethylcysteine antioxidants on superoxide dismutase enzyme.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 year
Severe trauma patients need to admit in an Intensive Care Unit
Exclusion criteria:
Incomplete demographic information
Preexisting conditions
Sepsis and organ failure
Drug sensitivity
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After determination of the sample size by block randomization method
patients divided into three groups of twenty patients (2 patientes in the case group1and 2 patients in case group 2 and 2 patients in control group)
Based on the time of patient entrance, patients divided into groups consist of 6patients then accidentaly each group divided into 3 sub group.To do randomization all ABC cases (AABBCC,ABCABC....)are considered.Then we put them on the envelopes and we arrange 6 groups of envelopes ,in each group, the group name was repeated 2 times.After evaluation of inclusion and exclusion criteria the selected patient or his family choose the pocket and the group. To blind patients and researchers ,the groups are placed in an envelope in the form of ABC.This process repeated for each patient to obtain the final sample size .
Blinding (investigator's opinion)
Single blinded
Blinding description
As the color and the shape of the drugs are the same, The patients did not know whic drugs they are getting .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Kerman University of Medical Sciences
Street address
Emam Highway.Afzalipour Hospital
City
kerman
Province
Kerman
Postal code
7616913911
Approval date
2019-08-13, 1398/05/22
Ethics committee reference number
IR.KMU.AH.REC.1398.069
Health conditions studied
1
Description of health condition studied
Sever Trauma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Superoxide dismutase
Timepoint
3 days after drug infusion
Method of measurement
Superoxide Dismutase Assay Kit
Secondary outcomes
1
Description
Organ function
Timepoint
3 days after drug infusion
Method of measurement
APACHI 2
2
Description
level of concsiousness
Timepoint
3days after drug infusion
Method of measurement
Glasco Coma Scale
3
Description
Duration of hospitalization
Timepoint
Days of hospitalization after drug infusion
Method of measurement
Days of hospitalization
Intervention groups
1
Description
Intervention group: Selanase vial 50 mcg in 10 cc.FIRST.Receive selenium in first day 1000 mcg over 24 hours.second day 400 mcg over24 hours.third day 200 mcg over24 hours.
Category
Treatment - Drugs
2
Description
Control group:Recieve Placebo=2fi00 cc normal saline over 24 hours for 3 days.
Category
Placebo
3
Description
Intervention group: Second.Recive N.Acetylcystein20% vial=first day 300mg per kilogram over 24 hours.second day 150mg per kilogram over 24 hours.third day 75 mg per kilogram over 24 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid bahonar hospital
Full name of responsible person
Farhad mazidi
Street address
Qarany st
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3211 8067
Email
lasadabadi@yahoo.c0m
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abass Pardakhty
Street address
Emam highway.Afzalipour
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Fax
+98 34 3226 3857
Email
abpardakhty@kmu.ac.ir
Web page address
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Leili Asadabadi
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No64.16 cross.shafa Ave
City
Kerman
Province
Kerman
Postal code
7618745477
Phone
+98 34 3211 8067
Email
lasadabadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Leili Asadabadi
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No.64, 16th cross, Shafa street, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7618745477
Phone
+98 34 3211 8067
Fax
Email
asadabadi.l@vums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Leili Asadabadi
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No.64, 16th cross, Shafa street, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7618745477
Phone
+98 34 3211 8067
Fax
Email
asadabadi.l@vums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information will be available after publishing.
When the data will become available and for how long
6 to 12 months
To whom data/document is available
All of researcher
Under which criteria data/document could be used
Person who research on patients admitted in intensive care units.
From where data/document is obtainable
Validated scientific journals
What processes are involved for a request to access data/document